A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00053378

Enrollment

Registered

2003-01-28

Start date

2002-01-31

Completion date

Unknown

Last updated

2006-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypocalcemia

Keywords

hypocalcemia, ionized calcium, intensive care

Brief summary

A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients

Interventions

DRUGparicalcitol injection (Zemplar)

BEHAVIORALEffects on calcium regulation

BEHAVIORALAdministration of elemental Ca during hypocalcemic ICU pts.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ICU patients APACHE III score between 70 - 150 at screening and within 24 hours of enrollment and a whole blood ionized calcium level less than 0.90 mmol/L or corrected whole blood calcium level less than or equal to 7.5 mg/dL.

Exclusion criteria

* Serum creatinine greater than 2.5 mg/dL

Design outcomes

Primary

Measure	Time frame
The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026